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FIBROVEIN 1% SOLUTION FOR INJECTION

Active substance(s): SODIUM TETRADECYL SULPHATE

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Pharmapac UK Ltd
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Pharmapac UK Ltd
Pharmacode No
FIBROVEIN SOLUTION FOR
Pharmacode No
FIBROVEIN SOLUTION
INJECTION
PreviousMaterial
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Material
FOR INJECTION
Previous Version
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L0029
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8
8

PACKAGE LEAFLET: INFORMATION FOR THE USER
Fibrovein 3%, 1%, 0.5% and 0.2% Solution for Injection
Sodium tetradecyl sulfate
you start using this medicine.

 If you have any further questions, please ask your doctor
or pharmacist.
 This medicine has been prescribed for you. Do not pass
it on to others. It may harm them, even if their symptoms are
the same as yours.
 If any of the side effects get serious, or if you notice any
or
pharmacist.
1.
2.
3.
4.
5.
6.

What Fibrovein is and what it is used for
What you need to know before you use Fibrovein
How to use Fibrovein
Possible side effects
How to store Fibrovein
Contents of the pack and other information

1. What Fibrovein is and what it is used for
The name of your medicine is Fibrovein, which contains the active
ingredient sodium tetradecyl sulfate.
Different strengths of Fibrovein are used in the treatment of
varicose veins, large, medium or minor venules and spider veins.
This injection belongs to a group of medicines called sclerosants.
Sclerosants are chemical agents, when injected into the affected
vein they cause the lining of the vein walls to swell and the walls
into
scar tissue. In a few weeks, the vein should fade.
Fibrovein is only for use in adults (including the elderly).
2. What you need to know before you use Fibrovein
You should not use Fibrovein if you:
• are allergic (hypersensitive) to sodium tetradecyl sulfate
or to any of the other ingredients in Fibrovein (listed in
section 6)
• cannot walk due to any reason

phlebitis)
• have blood clots in your veins (thrombosis)
• have risk of developing blood clots in your veins due to:
• inherited blood disorders such as thrombophilia

• immobility for long duration
• having hormonal contraception or hormone
replacement therapy.
• smoking
• have had recent surgery

or in the lungs
• have evolving cancer
• have twisted veins (varicose veins) caused by pelvic or
abdominal tumours, unless the tumour has been
removed
• have any kind of infection
• have an uncontrolled ailment such as diabetes, asthma,
blood abnormality, blood poisoning, or recent skin
or breathing problems
• have severe heart disease

shortness of breath.
• have blockage in an artery
• have been told that you have problems with closing of
valves in deep veins (valvular incompetence)
• have a symptomatic hole in the heart (only if the
sclerosant is used as a foam)
The following information is intended for healthcare
professionals only:
Fibrovein 0.2% Solution for Injection
Fibrovein 0.5% Solution for Injection
Fibrovein 1% Solution for Injection
Fibrovein 3% Solution for Injection
Please refer to the Summary of Product Characteristics (SmPC)
for further details of this product.
Qualitative and Quantitative Composition
Fibrovein 0.2% Solution for Injection
Each ml solution for injection contains 2mg Sodium Tetradecyl
Sulfate.
Each 5 ml vial contains 10 mg Sodium Tetradecyl Sulfate.
Fibrovein 0.5% Solution for Injection
Each ml solution for injection contains 5mg Sodium Tetradecyl
Sulfate.
Each 2 ml ampoule contains 10 mg Sodium Tetradecyl Sulfate.
Fibrovein 1% Solution for Injection
Each ml solution for injection contains 10mg Sodium Tetradecyl
Sulfate.
Each 2 ml ampoule contains 20 mg Sodium Tetradecyl Sulfate.
Fibrovein 3% Solution for Injection
Each ml solution for injection contains 30mg Sodium Tetradecyl
Sulfate.
Each 2 ml ampoule contains 60 mg Sodium Tetradecyl Sulfate.
Each 5 ml vial contains 150 mg Sodium Tetradecyl Sulfate.
For a full list of excipients, see List of Excipients below.
Pharmaceutical Form
Solution for injection.
A clear, colourless, sterile solution.
Contains benzyl alcohol 20mg/ml.
pH 7.5 – 7.9.
Osmolarity 247 – 273 mOsm/kg.
Therapeutic Indications
For the treatment of uncomplicated primary varicose veins,
recurrent or residual varicose veins following surgery, reticular
veins, venules and spider veins of the lower extremities that show
simple dilation.
Fibrovein is indicated in adults (including the elderly).
Posology and Method of Administration
Fibrovein is for intravenous use only. The strength of solution
required depends on the size and degree of varicosity. Spider
veins should only be treated with the 0.2%, reticular veins with
0.5%, the 1% solution will be found most useful for small to
medium varicosities and the 3% solution for larger varicosities.
The sclerosant should be administered intravenously in small

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4.COL PROCESS
4 COL

Talk to your doctor before using Fibrovein if you:
• are allergic to any food or medicine or have any other
allergies, you should speak to the doctor before being
given this injection, so that a test dose can be given 24 hours
before any further therapy
• have been told that you have any disease of your arteries or
veins (atherosclerosis)

the lungs

affecting the hands and feet (Buerger’s disease)

• have been told a surgical treatment is required to correct a
valve in the blood vessel
• have a hole in the heart
• suffer from migraine
• have a history of pulmonary hypertension
• have a history of stroke or serious cerebral event
Fibrovein should be administered only by experienced healthcare
professionals experienced in venous anatomy and familiar with
proper injection technique. Before using this injection you may
be tested to see if you have any problems with the closing of the
valves in your veins.
Your doctor will ask you questions about your health and will
inform you about the potential side effects of this procedure.
Your doctor will monitor you during and after the sclerotherapy for
signs of hypersensitivity (redness, itching, cough) or neurological
symptoms (visual disorders, migraine, tingling or numbness).
He will ask you to come back for a follow up visit.
Taking other medicines
Please tell your doctor or nurse if you are taking or have recently
taken any other medicines, including medicines obtained without
a prescription.
Pregnancy and breast-feeding
You must tell the doctor if:
• you are pregnant or think you may be pregnant
• you are planning on becoming pregnant
• you are breast-feeding
There is no adequate information on the use of Fibrovein in
pregnant women. Fibrovein should not be used during pregnancy
unless clearly necessary. Your doctor will decide whether or not
this treatment is appropriate for you.
It is not known whether Fibrovein is excreted in breast-milk. If
you are breast-feeding, the doctor will decide whether Fibrovein
should be used.
Driving and using machinery
After the treatment with this injection, you may be told to wear
a bandage and/or compression stockings to help reduce
ability to drive.
3. How to use Fibrovein
You must not
be treated by an experienced doctor who is familiar with the
injection technique.
The therapy involves injecting the medicine into the affected vein
using the smallest of the needles and it is to be injected slowly
and with extreme care so that the blood content of these veins is
expelled. The medicine may be manually mixed with air using two
syringes and a connector to create a foam to help expel the blood
in larger veins. In this case, it must be administered by a physician
appropriately trained in the correct generation and administration
of foam.
Your doctor should use ultrasound guidance in the treatment of non
visible varicose veins and for the administration of foam sclerosant.
Your doctor will decide on the areas to treat and the right dose for
you. The usual doses are as follows:
aliquots at multiple sites along the vein to be treated either as
a liquid or as a sclerosant/air mixture (foam) as detailed in the
table below. The objective is to achieve optimal destruction of
the vessel wall with the minimum concentration of sclerosant
necessary for a clinical result. If the concentration is too high
necrosis or other adverse sequelae may occur.
Refer below for instructions for foam preparation. The Tessari
method of preparation of the foam is described. Other techniques
may be used (e.g. DSS, Easyfoam, Sterivein).
Strict aseptic technique must be maintained while handling
Fibrovein. Fibrovein is a single-use parenteral product. Once the
container is opened, use immediately and discard any unused
portion. Visually inspect for particulate matter before use.
Solutions that contain particulate matter should not be used.
This medicinal product is not compatible with heparin.
In the absence of compatibility studies, this medicinal product
should not be mixed with other medicinal products.
Recommended doses and dosage schedules
Adults/Elderly
Normal volume injected
intravenously at suitable
sites
Liquid
Foam*
0.5 to 2ml
0.5 to 2ml
Fibrovein 3%
0.1 to 1ml
0.5 to 2ml
Fibrovein 1%
Not
Fibrovein 0.5%,
0.1 to 1ml
applicable
0.2%
Concentration

Maximum total
volume to be
injected
Liquid Foam*
4ml
16ml
10ml 16ml
Not
10ml
applicable

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Where special caution is indicated (see SmPC) it is recommended
that a test dose of 0.25 to 0.5ml Fibrovein should be given
followed by observation of the patient for several hours before
administration of a second or larger dose.
For spider veins the smallest of needles (for example 30 gauge)
should be used to perform the injection which should be made
slowly so that the blood content of these veins is expelled. In the
treatment of spider veins an air block technique may be used.
When the sclerosant is administered as a foam it should ideally be
administered under ultrasound guidance. It must be administered
by a physician appropriately trained in the correct generation and
administration of the foam.
Special warnings and precautions
Fibrovein should only be administered by a healthcare
professional experienced in venous anatomy and the diagnosis
and treatment of conditions affecting the venous system
and familiar with proper injection technique. Severe adverse
local effects, including tissue necrosis, may occur following

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urs
rs

or
r

Adults
Adultsand
andthe
theelderly
elderly
•• varies
variesbetween
between0.1
0.1and
and22ml
mlfor
foreach
eachinjection.
injection.AAmaximum
maximum
ofof10
10ml
mlofofthe
thethree
threelower
lowerstrength
strengthinjections
injectionsmay
maybe
beused,
used,
however
howeverno
nomore
morethan
than44ml
mlisisused
usedwhen
whenthe
thestrongest
strongest
injection
injectionisisused.
used.
Due
Duetotothe
thelimited
limitedvolume
volumeofofsclerosant
sclerosantauthorised,
authorised,repeated
repeated
sessions
sessionsofofsclerotherapy
sclerotherapymay
maybe
benecessary.
necessary.
Children
Children
•• Fibrovein
Fibrovein isisnot
notintended
intendedfor
foruse
usefor
forchildren.
children.
After
Afteryou
youhave
havebeen
beentreated
treatedwith
withFibrovein,
Fibrovein,you
youshould
shouldfollow
follow
your
yourdoctor’s
doctor’sadvice.
advice.You
Youmay
maybe
betold
toldtotowear
wearaabandage
bandageand
and
pigmentation
pigmentationofofthe
theskin.
skin.
4.4.Possible
Possibleside
sideeffects
effects

are
re

ee

or
for
alal

yy
utt

cy
y
t

n

rr

nn

ss
wo
wo
od
od
an
ian
nn

Like
Likeall
allmedicines,
medicines,Fibrovein
Fibroveincan
cancause
causeside
sideeffects,
effects,although
althoughnot
not
everybody
everybodygets
getsthem.
them.
The
Themost
mostserious
seriousside
sideeffect
effectisisaavery
verysevere
severeform
formofofallergic
allergic
reaction
reaction(anaphylactic
(anaphylacticshock).
shock).ItItisisextremely
extremelyrare
rarebut
butshould
shouldbe
be
treated
treatedimmediately,
immediately,otherwise
otherwiseititmay
maybe
befatal.
fatal.Also
Alsoaablood
bloodclot
clotinin
the
thelungs
lungsisisvery
veryrare.
rare.To
Toavoid
avoidthis
thisvery
veryrare
rareserious
seriousevent,
event,this
this
product
productisiscontra-indicated
contra-indicatedininpatients
patientswho
whohave
haveaarisk
riskofofclots
clotsinin
veins
veinsand
andarteries
arteries(risk
(riskofofthrombosis).
thrombosis).
The
Themost
mostcommon
commonside
sideeffects
effectsare
arepain
painatatthe
thesite
siteofofinjection,
injection,red
red
itchy
itchyskin
skin(hives),
(hives),temporary
temporarydiscolouration
discolourationofofthe
theskin,
skin,super
super
Other
Otherside
sideeffects
effectsthat
thatmay
maybe
beexperienced
experiencedare:
are:
Common
Common(at
(atleast
least11inin100
100but
butless
lessthan
than11inin10
10patients):
patients):
Pain
Painororburning
burning(short
(shortterm
termatatthe
theinjection
injectionsite)
site)
Skin
Skindiscolouration
discolouration
Uncommon
Uncommon(at
(atleast
least11inin1,000
1,000but
butless
lessthan
than11inin100
100
patients):
patients):
Local
Localallergic
allergicand
andnon
nonallergic
allergicskin
skinreactions
reactionse.g.
e.g.redness
rednessofofskin,
skin,
itchy
itchyskin,
skin,rash
rashororswelling
swellingofofthe
theskin
skin
Blood
Bloodclots
clotsinindeep
deepveins
veins(deep
(deepvein
veinthrombosis
thrombosispossibly
possiblydue
duetoto
underlying
underlyingdisease)
disease)
Visual
Visualdisturbances
disturbances(if(ifadministered
administeredas
asaafoam)
foam)
Rare
Rare(at
(atleast
least11inin10,000
10,000but
butless
lessthan
than11inin1,000
1,000patients):
patients):
Local
Localtissue
tissuedeath
deathofofskin
skinand
andmore
morerarely
rarelyofofnerves
nerves
Coughing,
Coughing,shortness
shortnessofofbreath,
breath,sensation
sensationofofpressure/tightness
pressure/tightness
ininthe
thechest
chest
Burning,
Burning,tingling,
tingling,prickling
pricklingororitching
itchingofofthe
theskin
skin
Headache,
Headache,migraine,
migraine,feeling
feelingfaint
faint
Confusion,
Confusion,dizziness,
dizziness,loss
lossofofconsciousness
consciousness
Very
Veryrare
rare(less
(lessthan
thanor
or11inin10,000
10,000patients):
patients):
allergic
allergicreactions
reactions(anaphylactic
(anaphylacticshock)
shock)
Nausea,
Nausea,vomiting,
vomiting,diarrhoea,
diarrhoea,feeling
feelingofofswollen/thick
swollen/thicktongue,
tongue,dry
dry
mouth
mouth
Visual
Visualdisturbances
disturbances(if(ifadministered
administeredas
asaaliquid)
liquid)
Weakness,
Weakness,stroke
strokelike
likesymptoms
symptoms
Blockage
Blockageofofartery
arterydue
duetotoaaclot
clot(stroke,
(stroke,transient
transientischemic
ischemicattack,
attack,
pulmonary
pulmonaryembolism)
embolism)
Death
Deathofoftissue
tissuefollowing
followingintra-arterial
intra-arterialinjection
injection
IfIfyou
youexperience
experienceany
anyserious
seriousside
sideeffects
effectsororfeel
feelthat
thatthe
themedicine
medicine
isisaffecting
affectingyou
youbadly
badlytell
tellyour
yourdoctor
doctorororpharmacist
pharmacistimmediately.
immediately.
5.5.How
Howto
tostore
storeFibrovein
Fibrovein

on
on
nt.
t.
or
for

Keep
Keepout
outthe
thereach
reachand
andsight
sightofofchildren
children
•• This
Thismedicinal
medicinalproduct
productdoes
doesnot
notrequire
requireany
anyspecial
specialstorage
storage
conditions
conditions
•• Do
Donot
notfreeze
freeze
•• The
Theinjection
injectionshould
shouldbe
bestored
storedininthe
theouter
outercarton
cartontotoprotect
protectitit
from
fromlight
light

es
s

extravasation;
extravasation;therefore,
therefore,extreme
extremecare
careininintravenous
intravenousneedle
needle
placement
placementand
andusing
usingthe
theminimal
minimaleffective
effectivevolume
volumeatateach
each
injection
injectionsite
siteare
areimportant.
important.The
Thesolution
solutionshould
shouldbe
beinjected
injectedslowly.
slowly.
Care
Careshould
shouldbe
betaken
takennot
nottotoinject
injectthe
thesolution
solutioninto
intoan
anartery
arteryas
as
this
thismay
maylead
leadtotodeath
deathofofthe
thetissue
tissue(tissue
(tissuenecrosis)
necrosis)and
andmay
may
result
resultininloss
lossofofthe
thelimb.
limb.
Special
Specialcare
caremust
mustbe
betaken
takenwhen
wheninjecting
injectingthe
thefoot
footand
andabove
aboveand
and
below
belowthe
theankle
ankle(malleolar
(malleolararea)
area)due
duetotorisk
risktotoone
oneofofthe
thearteries.
arteries.
Compression
Compressionmust
mustbe
beapplied
appliedwhen
whentreating
treatingsmaller
smallerveins
veinsas
as
pigmentation
pigmentationmay
mayoccur
occurififblood
bloodisisexpelled
expelledatatthe
theinjection
injectionsite.
site.
Allergic
Allergicreactions
reactionsincluding
includinganaphylaxis
anaphylaxishave
havebeen
beenreported
reported
and
andthe
thephysician
physicianshould
shouldbe
beprepared
preparedtototreat
treatititappropriately.
appropriately.
Emergency
Emergencyresuscitation
resuscitationequipment
equipmentshould
shouldbe
beimmediately
immediately
available.
available.
The
Thepatient
patientshould
shouldbe
betreated
treatedininhospital
hospitalas
asaaprecaution.
precaution.

ee

ele

ded
ed

To
ToPrepare
Preparethe
theFoam
Foam(Tessari
(Tessaritechnique)
technique)
Strict
Strictaseptic
aseptictechnique
techniquemust
mustbe
bemaintained
maintainedwhile
whilemanufacturing
manufacturing
the
thefoam.
foam.
To
Tocreate
createthe
thefoam
foam1ml
1mlofofliquid
liquidsclerosant
sclerosantisisdrawn
drawninto
intoaasterile
sterile
syringe
syringeand
and3ml
3mloror4ml
4mlofofsterile
sterileair
airisisdrawn
drawninto
intoanother
anothersterile
sterile
ss
sterile.
sterile.The
Thesyringes
syringesare
arethen
thenconnected
connectedusing
usingaasterile
sterilethree
threeway
way
tap/valve
tap/valve(Fig.
(Fig.1).
1).
The
Thesclerosant/air
sclerosant/airmixture
mixtureisisthen
thenforced
forcedback
backand
andforth
forthfrom
fromone
one
syringe
syringetotothe
theother
otherthrough
throughthe
the3-way
3-wayvalve
valveapproximately
approximately20
20
times
timestotoproduce
produceaasmooth,
smooth,consistent
consistentfoam
foam(Fig.
(Fig.2&3).
2&3).
The
Thesyringe
syringecontaining
containingthe
thefoam,
foam,isisthen
thenremoved
removedand
andthe
thevein
veinisis
Fig
Fig11

Fig22
Fig

Fig
Fig33

Fig
Fig44

be
be
ed
d
nd
d

i

5

6.6.Contents
Contentsof
ofthe
thepack
packand
andfurther
furtherinformation
information
What
WhatFibrovein
Fibrovein contains
contains
The
Theactive
activeingredient
ingredientis:
is:sodium
sodiumtetradecyl
tetradecylsulfate.
sulfate.
For
Forthe
the0.2%:
0.2%:
Each
Eachml
mlofofsolution
solutionfor
forinjection
injectioncontains
contains2mg
2mg Sodium
SodiumTetradecyl
Tetradecyl
Sulfate.
Sulfate.
Each
Each55ml
mlvial
vialcontains
contains10
10mg
mgSodium
SodiumTetradecyl
TetradecylSulfate.
Sulfate.
For
Forthe
the0.5%:
0.5%:
Each
Eachml
mlofofsolution
solutionfor
forinjection
injectioncontains
contains5mg
5mg Sodium
SodiumTetradecyl
Tetradecyl
Sulfate.
Sulfate.
Each
Each22ml
mlampoule
ampoulecontains
contains10
10mg
mgSodium
SodiumTetradecyl
TetradecylSulfate.
Sulfate.
For
Forthe
the1%:
1%:
Each
Eachml
mlofofsolution
solutionfor
forinjection
injectioncontains
contains10mg
10mg Sodium
Sodium
Tetradecyl
TetradecylSulfate.
Sulfate.
Each
Each22ml
mlampoule
ampoule contains
contains20mg
20mgSodium
SodiumTetradecyl
TetradecylSulfate.
Sulfate.
For
Forthe
the3%:
3%:
Each
Eachml
mlofofsolution
solutionfor
forinjection
injectioncontains
contains30mg
30mg Sodium
Sodium
Tetradecyl
TetradecylSulfate.
Sulfate.
Each
Each2ml
2mlampoule
ampoule contains
contains60mg
60mgSodium
SodiumTetradecyl
TetradecylSulfate.
Sulfate.
Each
Each5ml
5mlvial
vial contains
contains150mg
150mgSodium
SodiumTetradecyl
TetradecylSulfate.
Sulfate.
The
Theother
otheringredients
ingredientsare:
are:benzyl
benzylalcohol
alcohol(20
(20mg/ml),
mg/ml),disodium
disodium
phosphate
phosphatedodecahydrate,
dodecahydrate,potassium
potassiumdihydrogen
dihydrogenphosphate,
phosphate,
water
waterfor
forinjections,
injections,sodium
sodiumhydroxide
hydroxide(to
(toadjust
adjustthe
thepH).
pH).
What
WhatFibrovein
Fibrovein looks
lookslike
likeand
andthe
thecontents
contentsof
ofthe
thepack
pack
This
Thismedicinal
medicinalproduct
productisispresented
presentedas
asaasolution
solutionfor
forinjection
injectioninin
clear
clearglass
glassampoules
ampoulesororvials.
vials.The
Thesolution
solutionisisclear
clearand
andcolourless.
colourless.
For
Forthe
the0.2%:
0.2%:pack
packsize
size2,2,55oror10
10vials
vialsofof55ml
ml
For
Forthe
the0.5%:
0.5%:pack
packsize
sizeofof55ampoules
ampoulesofof22ml
ml
For
Forthe
the1%:
1%:pack
packsize
sizeofof55ampoules
ampoulesofof22ml
ml
For
Forthe
the3%:
3%:pack
packsize
sizeofof55ampoules
ampoulesofof22ml
mloror2,2,55oror10
10vials
vialsofof
55ml
ml
Not
Notall
allpack
packsizes
sizesmay
maybe
bemarketed.
marketed.
Marketing
MarketingAuthorisation
AuthorisationHolder:
Holder:
STD
STDPharmaceutical
PharmaceuticalProducts
ProductsLtd.
Ltd.
Plough
PloughLane,
Lane,Hereford,
Hereford,HR4
HR40EL,
0EL,United
UnitedKingdom
Kingdom
Manufacturer:
Manufacturer:
STD
STDPharmaceutical
PharmaceuticalProducts
ProductsLtd.
Ltd.
Plough
PloughLane,
Lane,Hereford,
Hereford,HR4
HR40EL,
0EL,United
UnitedKingdom
Kingdom
This
Thismedicinal
medicinalproduct
productisisauthorised
authorisedininthe
theMember
MemberStates
Statesofofthe
the
EEA
EEAunder
underthe
thefollowing
followingnames:
names: UK,
UK,FR,
FR,PT
PTand
andCZ:
CZ:Fibrovein
Fibrovein
ES
ESVeinfibro
Veinfibro
Other
Othersources
sourcesof
ofinformation:
information:
print
printoror
audio
audioplease
pleasecall,
call,free
freeofofcharge:
charge:0800
0800198
1985000
5000(UK
(UKOnly).
Only).
Please
Pleasebe
beready
readytotogive
givethe
thefollowing
followinginformation:
information:
Product
Reference
ProductName
Name
ReferenceNumber
Number
Fibrovein
PL
Fibrovein3%
3%
PL00398/0207
00398/0207
Fibrovein
PL
Fibrovein1%
1%
PL00398/0206
00398/0206
Fibrovein
PL
Fibrovein0.5%
0.5%
PL00398/0205
00398/0205
Fibrovein
PL
Fibrovein0.2%
0.2%
PL00398/0204
00398/0204
This
Thisisisaaservice
serviceprovided
providedby
bythe
theRoyal
RoyalNational
NationalInstitute
InstituteofofBlind
Blind
People.
People.
on

14

The
Thequality
qualityofofthe
thefoam
foamshould
shouldbe
bechecked
checkedbefore
beforeits
its
administration.
administration.ItItshould
shouldappear
appearhomogenous
homogenouswith
withno
nolarge
large
bubbles
bubblesvisible
visibletotothe
thenaked
nakedeye.
eye.
1.1. The
Theproduct
productconcentration:
concentration:Foam
Foamcan
canonly
onlybe
beprepared
preparedwith
with
concentrations
concentrationsofof11toto3%
3%sodium
sodiumtetradecyl
tetradecylsulfate.
sulfate.
2.2. The
Theproportion
proportionofofliquid
liquidtotoair:
air:Usually,
Usually,this
thisproportion
proportionisis11
volume
volumeofofliquid
liquidfor
for33volumes
volumesofofair.
air.
3.3. Number
Numberofofbackwards
backwardsand
andforwards
forwardspasses:
passes:The
Thephysician
physician
each
eachtechnique.
technique.
4.4. Macroscopic
Macroscopicconsistency
consistencyofofthe
thefoam:
foam:The
Thequality
qualityofof
the
thefoam
foamshould
shouldbe
bechecked
checkedoutside
outsideofofthe
thesyringe
syringe
before
beforeadministration.
administration.The
Thefoam
foamshould
shouldbe
behomogeneous,
homogeneous,
soft
softand
andcohesive
cohesivewith
withno
novisible
visiblelarge
largebubbles.
bubbles.IfIf
large
largebubbles
bubblesare
arevisible,
visible,the
thefoam
foamshould
shouldbe
bethrown
thrown
away
awayand
andnew
newfoam
foamprepared.
prepared.
5.5. The
Thetotal
totaltime
timeofofpreparation
preparationofofthe
thefoam:
foam:The
Thepreparation
preparation
last
lastbackwards
backwardsand
andforwards
forwardsmovement.
movement.
6.6. The
Themaximum
maximumtime
timebetween
betweenpreparation
preparationand
andinjection:
injection:
The
Thesclerosant
sclerosantfoam
foammust
mustbe
beused
usedwithin
withinsixty
sixtyseconds
secondsofof
production.
production.After
Aftersixty
sixtyseconds,
seconds,any
anyremaining
remainingfoam
foamshould
shouldbe
be
discarded.
discarded.More
Morefoam
foamshould
shouldbe
beprepared
preparedififrequired.
required.
Pharmaceutical
PharmaceuticalParticulars
Particulars
List
Listof
ofexcipients
excipients
Benzyl
Benzylalcohol
alcohol
Disodium
Disodiumphosphate
phosphatedodecahydrate
dodecahydrate
Potassium
Potassiumdihydrogen
dihydrogenphosphate
phosphate
Sodium
Sodiumhydroxide
hydroxide (for
(forpH
pHadjustment)
adjustment)
Water
Waterfor
forinjections
injections
Shelf
Shelflife
life
33years.
years.

)

ee

•• Fibrovein
Fibrovein should
shouldnot
notbe
beused
usedafter
afterthe
theexpiry
expirydate
dategiven
givenon
onthe
the
carton;
carton;the
theexpiry
expirydate
daterefers
referstotothe
thelast
lastday
dayofofthe
themonth.
month.
For
Forsingle
singleuse
useonly.
only.Once
Oncethe
thecontainer
containerisisopened,
opened,the
thecontents
contents
should
shouldbe
beused
usedimmediately.
immediately.Any
Anyremaining
remainingproduct
productshould
shouldbe
be
discarded.
discarded.
Medicines
Medicinesshould
shouldnot
notbe
bedisposed
disposedofofvia
viawastewater
wastewaterororhousehold
household
waste.
waste.Ask
Askyour
yourpharmacist
pharmacisthow
howtotodispose
disposeofofmedicines
medicines
no
nolonger
longerrequired.
required.These
Thesemeasures
measureswill
willhelp
helpprotect
protectthe
the
environment.
environment.

injected
injectedimmediately
immediately(Fig.
(Fig.4).
4).
The
Thesclerosant
sclerosantfoam
foamshould
shouldbe
beused
usedwithin
withinsixty
sixtyseconds
secondsofof
production.
production.After
Aftersixty
sixtyseconds
secondsany
anyremaining
remainingfoam
foamshould
shouldbe
be
discarded.
discarded.More
Morefoam
foamshould
shouldbe
beprepared
preparedififrequired.
required.

40023_L0029_P1
40023_L0029_P1
22
SO42722_L0048_P1.indd
SO42722_L0048_P1.indd
SO42722_L0048_P2.indd
SO42722_L0048_P2.indd
22
SO42722_L0048_P4.indd

Special
Specialprecautions
precautionsfor
forstorage
storage
This
Thismedicinal
medicinalproduct
productdoes
doesnot
notrequire
requireany
anyspecial
specialstorage
storage
conditions.
conditions.
Do
Donot
notfreeze.
freeze.
Keep
Keepthe
thevial/ampoule
vial/ampouleininthe
theouter
outercarton
cartonininorder
ordertotoprotect
protectfrom
from
light.
light.
Nature
Natureand
andcontents
contentsofofcontainers
containers
5ml
5mlvials
vials(Type
(Type11glass)
glass)with
withaastopper
stopperand
andaluminium
aluminiumseal
sealwith
with
2ml
2mlampoules
ampoules(Type
(Type11glass).
glass).
Special
Specialprecautions
precautionsfor
fordisposal
disposal
There
Thereare
areno
nospecial
specialrequirements
requirementsfor
fordisposal.
disposal.
L0048
L0048

14/06/2013
14/06/201312:51
10:39
10:39
22/07/2014
22/07/2014
12:51
23/07/2014
23/07/2014
14:38
14:38
11/09/2014
13:33

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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